Blood collection device

ABSTRACT

The present invention involves an integrated double-ended needle and blood collection device assembly which is convenient to use, safely contained and ready for disposal after use. The device allows the user to expose and resheath potentially infectious needles without bringing the user&#39;s fingers or hands into close proximity with sharp or broken needle tips. After removing the needle from the patient, the needle is safely resheathed by retracting the needle into the device, thereby reducing the risks of accidental needle wounds and infection. The device also serves as a holder for blood collection tubes which can be easily inserted and removed for multiple sampling.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an integrated assembly and apparatusfor the collection of multiple samples of blood specimens. The inventionfurther relates to an apparatus for drawing blood samples, wherein adouble-ended needle is sheathed before use and safely resheathed afteruse, thereby reducing the risk of accidental needle wounds and resultantinfections to a minimum. In another aspect, the invention relates to ablood collection device and integrated double-ended needle, wherein atno time is it necessary to cap or cut-off an exposed needle after use.

2. Related Art

Apparatus typically used to perform phlebotomy are septum-cappedevacuated tubes which are used with double-ended hollow needles orsharpened cannulae, one end of which is inserted into the patient andthe other end pierces the septum, thereby withdrawing a volume of blood.Prior to disposal of the needle, the needle is either capped orbroken-off to prevent reuse.

It is customary to use sterile, single use, disposable devices fortaking blood samples from patients just as single use, disposable,sterile hypodermic needles are widely used for administering therapeuticagents. While these conventional single use, disposable devices fullyprotect the patient from the dangers of infectious diseases, such asAIDS and certain hepatitis viruses, they present a risk of infection tomedical and hospital personnel due to accidental wounding with acontaminated needle or contact with other contaminated parts of thedisposable apparatus. Normally, health care workers are especiallysusceptible to accidental and potentially infectious needle wounds dueto the careless handling or breaking of the needle in disposing of thesyringe after use. Accidental needle wounds generally result in the needfor blood tests for such diseases as AIDS and hepatitis. Thecorresponding costs and inefficiency of testing health care workers whohave received an inadvertent needle wound result in a considerable wasteof resources, which may be particularly damaging to a health carefacility, as well as an ever present danger to the worker personally.

Widely used commercial devices for blood collection includedouble-ended, multiple sample needles having protective caps over bothneedle ends for storage. The needle holder for such a needle is oftenseparate from the needle and reusable. The risk of a needle wound to theuser, especially when recapping the needle after drawing a sample, isunacceptably high. In addition, the destruction of the needle in aclipping device has been recommended, but this is also a hazardouspractice because of aerosol production of contaminated blood samples,the continued risk of wounds from the resultant blunt needle shaft andthe hazards uncapped needles present to waste disposal personnel.Furthermore, it is not always practical to carry a needle clippingdevice from patient to patient in a hospital or clinic environment.

SUMMARY OF THE INVENTION

The present invention involves a novel blood collection device suitablefor use with a double-ended needle. The device includes a tube havingforward and rear ends with at least one longitudinal external slot inthe tube wall. The external slot terminates in a first transverse slotextension in the forward end portion of the tube and a second transverseslot extension in the rear end portion of the tube. The tube forward endterminates in a needle sheath which is axially aligned with the axis ofthe double-ended needle, and the tube rear end terminates with an opentube bore. The double-ended needle is mounted centrally andperpendicularly through a support member which is slideably positionedin the bore of the tube and is capable of movement along the tube borebetween the tube forward end portion and the tube rear end portion. Thesupport member has arm means secured thereto, wherein the arm meansprojects through the longitudinal external slot of the tube and ismovable in a slideable and rotatable manner from one transverse slotextension to another transverse slot extension, thereby enabling theuser to secure the support member in either a forward end position or arear end position. When the support member is secured in the forward endposition, the needle is extended from the device. When the supportmember is secured in the rear end position, the needle is withdrawn intothe device.

The support member can be a substantially rigid disc which is rotatablyand slideably encased within the tube bore. The disc has a center axis,axially aligned with the axis of the tube bore, and generally includestwo finger tabs connected to the disc by the arm means which areslideably positioned in and through two longitudinal external slots inthe tube wall. In a preferred embodiment of the invention, thetransverse slot extensions include a detaining means whereby the movablearm is secured within the forward or rear transverse slot extension,thereby locking the needle in either an extended or sheathed position.After withdrawal of the needle from the patient, the finger tabs can berotated, unlocked, pulled back and rotated into a retracted lockedposition either with or without the needle having been clipped. Theentire assembly is then safely contained and ready for disposal.

In an alternative embodiment, the needle sheath can be capped or coveredby needle sheath cap. For example, a holding ring on the needle sheathcan be used to secure the sheath cap by interlocking with an interiorgroove on the sheath cap. In yet another embodiment, the device caninclude a handling flange at the rear end of the tube to facilitatemanipulation of the device. In a further embodiment, the device includesa tube rear end cap to close the rear end of the tube, and optionally,the tube rear end cap can be connected to a needle sheath cap by aflexible connector.

In another preferred embodiment, the device can include an interior orexterior tube sleeve having at least one sleeve longitudinal slot whichis opposed to and of equal length to the tube longitudinal externalslot. The sleeve is rotatably mounted so that upon rotation the sleevecloses or covers the tube longitudinal external slot.

The integrated double-ended needle and blood collection device of thepresent invention provides an assembly which is highly simplified andconvenient to use. The assembly also serves as a holder of bloodcollection tubes during sample taking, with the collection tubes beingeasily inserted and removed through the rear bore opening of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of the blood collection device of thepresent invention in a retracted and unlocked position.

FIG. 2 is a side elevation view of the blood collection device with theneedle in an exposed position for use. Locking is accomplished byrotating the finger tabs in the direction of the arrow.

FIG. 3 is a front sectional view of the blood collection deviceincluding optional elements such as a tube rear end cap joined by aflexible connector to a needle sheath cap or cover; the front sectionview presents the device with the double-ended needle in a retractedposition for handling, shipping, or discarding. The finger tab is shownas a separate snap-in device installed in the needle support member.

FIG. 4 is a perspective view of the apparatus with the sample needlefully extended from the sheath, but without the finger tabs in a lockedposition. FIG. 4 further presents an optional outer sleeve which isrotatably mounted on the tube and covers the longitudinal external slotswhen the finger tabs are in either the retracted or the extended lockedposition.

FIG. 5 depicts the blood collection device with the sample end of theneedle fully extended from the device and an evacuated blood collectiontube positioned above and ready for placement upon the resealable coverof the rear needle end.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a novel blood sample device wherein thedouble-ended needle is completely sheathed in the device until neededfor use. The hands or fingers of the user need never approach the needleeither to place it into position for use or for resheathing anddisposal. The object of the blood collection device is the protection ofmedical, hospital and clinical users or others who might come in contactwith the device and integrated needle after use but prior to disposal.

Another object of the invention is to provide a blood collection device,having such safety features, and which is highly simplified andtherefore, relatively economical to manufacture, convenient to use,reliable in its operation and construction and operable in such a waythat the risk of spreading infection with a used device is significantlyreduced. Other objects and advantages of the invention will becomeapparent to those skilled-in-the-art from the following detaileddescription.

Referring to the drawings in detail, wherein like numbers designate likeparts, two main embodiments of the blood collection device areillustrated: an embodiment without a sleeve, FIGS. 1 and 2; and anembodiment involving an exterior sleeve, FIG. 4. Although the depictedblood collection devices are particularly useful in vacuum tubephlebotomy, i.e., the drawing one or more samples of blood intoindividual evacuated blood collection tubes, it will be appreciated thatthe safety features of the present invention are also applicable to asyringe with which a fluid is administered to a recipient by means ofappropriate injection procedures.

Referring initially to FIG. 1, a side elevation view of the device isdepicted, with the double-ended needle retracted in a safety positionfor handling, shipping and disposal. The numeral 2 designates theintegrated double-ended needle and blood collection device. The tube 4is an elongated rigid cylindrical body having a central longitudinaltube bore 6. The tube 4 has a closed forward end 8 and a tube forwardend portion 10. The tube 4 also has a tube rear end 12 and a tube rearend portion 14, with tube side wall 16 connecting tube rear end 12 andtube forward end 8. Within the tube side wall 16 are one or morelongitudinal slots, such as longitudinal external slot 18 andlongitudinal external slot 20 which are positioned in opposite geometry.Longitudinal slots 18 and 20 both include transverse slot extensions 22,in the forward end portion 10, which extensions are positionedcircumferentially in the same direction from the longitudinal slots. Thelongitudinal slots 18 and 20 also have rear end portion transverse slotextensions 24 circumferentially extending from the longitudinal slots inthe same direction as regard the rear end portion 14, but which extendin the opposite direction to transverse slot extensions 22 in theforward end portion 10.

The double-ended tubular needle 26 has a forward end 28 and a rear end30. A resealable septum or cover 32 encloses the tubular needle rear end30. The double-ended tubular needle 26 is mounted centrally andperpendicularly through rigid disc 34 or a similar support member meanshaving a central axis 3.

The rigid disc 34, as further illustrated in FIG. 4, has arms 38 and 40extending through longitudinal external slots 18 and 20 and connected tofinger tabs 42. The finger tabs 42 and connecting arms 38 and 40 enablethe positioning of the rigid disc 34 and mounted double-ended tubularneedle 26 into a retracted and locked position through locking means 44,whereby the double-ended tubular needle is totally encased within thedevice. The finger tabs 42, through arms 38 and 40, are used to move therigid disc 34 and double-ended tubular needle 26 forward from theretracted position. The arms are moved through longitudinal externalslots 18 and 20 and into the transverse forward slot extensions 22. Thearm means 38 and 40 lock in place through a detaining means 45 whereinthe tubular needle forward end 28 is fully extended outside the tube 4.

The finger tabs, arm means and detention means for positioning andsecuring the needle support member in a rear or forward position can becomprised of several configurations. The slot extensions 22 and 24 canbe constructed with detaining means 45 and 44, respectively, within thetransverse extension slot to hold the finger tabs and connected arms inplace, yet the arms can be easily unlocked through an upward or downwardpressure on the finger tabs. Such a locking means is only one example ofa simple yet effective method for securing the needle in its rear orforward position. The detaining means depicted in FIGS. 1 and 4 involvesa projecting portion 45 and 44 in both the forward and rear slotextensions 22 and 24, respectively, but could alternatively be an indentor notch which secures the arms within the transverse slot extensions.

A handling flange 46 can be positioned at the tube rear end 12 and canbe placed surrounding the open tube bore 52. The flange is convenientfor handling the device in general and as an aid for inserting andremoving an evacuated phlebotomy tube 68, as shown in FIG. 5.

The tube 4 has a needle sheath 48 on the tube forward end 8. FIG. 3illustrates that the needle sheath 48 can optionally include a holdingring 50 which secures a needle sheath cap or cover 64 to the needlesheath when the double-ended tubular needle 26 is fully retracted. Theneedle sheath 48, by means of the holding ring 50, secures the sheathcap 64 by interlocking with an interior groove 66 in the sheath cap. Inaddition, FIG. 3 illustrates an optional tube rear end cap 56 locked inplace through the operation of a cap securing lip 54 which when combinedwith the tube rear handling flange 46 fixes the tube rear end cap to thedevice for handling and/or disposal. Optionally, the tube rear end cap56 is joined to the sheath cap 64 by a flexible connector 60.

The tube rear end cap 56 is shown to be larger in size than handlingflange 46, allowing the tube rear end cap to cover the handling flangeand be secured by means of a snap-fit mechanism. In an alternativeembodiment, a snap-fit cap, could involve an inside fitting means, notshown.

In FIG. 4, a perspective view is shown of the apparatus including anexterior tube sleeve 41 having sleeve longitudinal slots 43. The sleevelongitudinal slots 43 are coradial and adjacent to and of equal lengthto longitudinal slots 18 and 20 in the tube side wall 16. There are notransverse slot extensions present in the exterior sleeve 41. Thedouble-ended needle forward end 28 is shown as fully extended from theneedle sheath 48. The finger tabs 42 are depicted in an unlockedposition, as the exterior sleeve 41 has not been turned to allow the arminto the slot extensions 22 and into contact with the detention means45.

In one embodiment of the invention, the novel blood collection deviceincludes the rotatable sleeve positioned inside the needle tube bore. Analternative embodiment involves the use of the rotatable sleeve on theoutside of the tube. The sleeve, whether inside or outside the tube,presents no change in the function of the needle support member, slotmeans or detention means. The construction of the device allows thesleeve to freely rotate co-axially to the needle tube, while at the sametime preventing the sleeve from sliding in a direction parallel to thecentral axis of the needle tube. The purpose of the sleeve, as anoptional feature of the invention, is to close the longitudinal externalslots through which the finger tabs travel during needle sheathing andunsheathing manipulations. When the finger tabs are twisted into thelocked position with the needle either fully extended or fullyretracted, the sleeve will cover the slots in the tube wall, therebyminimizing the release of aerosol blood or blood droplets created whenan evacuated blood collection tube is removed from the double-endedneedle. In addition, the sleeve will minimize the leakage of blood dropswhich may form if the double-ended needle's self-sealing cover does notclose-off the flow of blood when the evacuated blood collection tube isremoved.

FIG. 5 presents a side elevation view of the integrated double-endedneedle and blood collection device 2, with the hollow needle forward end28 fully extended from the tube 4. The figure also shows the use of anevacuated phlebotomy blood collection tube 68 having a rubber septum 70which seals the evacuated tube. When the tube is placed in position onthe tubular needle rear end 30, and is forced into contact with and overthe tubular needle rear end 30, the resealable needle cover 32 ispenetrated as is the septum 70, thereby allowing communication betweenthe tubular needle forward end 28, which is in the patient, and theinterior of the evacuated tube. By removing filled tubes and insertingnew evacuated tubes 68, multiple samples can be taken without removingthe tubular needle forward end 28 from the patient.

When the last blood sample has been taken, the double-ended needleforward end 28 is withdrawn from the patient. To prevent an accidentalneedle injury and the possible spread of contagious disease from acontaminated needle, the user can unlock the finger tabs 42 andslideably retract the double-ended needle 26 into the tube bore 6. Therear detention means can then be engaged, whereby the double-endedneedle is totally enclosed within the device in the retracted position.By grasping the tabs and handling flange as well as the tubular body,the user should never have need for placing fingers in the proximity ofthe exposed needle.

The double-ended needle can be utilized from readily availablecommercial sources and removably affixed to the needle support memberwhich will allow the reuse of the remainder of the device with a newdouble-ended needle. The major benefit of the present invention,however, is the concept of an integrated double-ended needle and bloodcollection device wherein the needle is resheathed totally within thedevice for disposal.

It will be appreciated by one skilled-in-the-art that the selection ofany given detention means, component size or appearance is generally notcritical to the present invention. The sizes and relative angles of thecomponent pieces are selected to optimize the manipulation of thedevice. The embodiments described herein are intended as examples ratherthan as limitations. Thus, the description of the invention is notintended to limit the invention to the particular embodiments describedin detail, but it is intended to encompass all equivalents and subjectmatter within the spirit and scope of the invention as described aboveand as set forth in the following claims.

What is claimed is:
 1. A blood collection device, for use with adouble-ended needle, comprising:a tube having forward and rear ends andat least one longitudinal external slot having a first transverse slotextension in said tube at a forward end portion and a second transverseslot extension in said tube at a rear end portion, said tube rear endterminating with an open tube bore; a needle sheath, axially alignedwith the axis of the double-ended needle, at said tube forward end; asupport member slideably positioned in said tube bore for movement alongsaid tube bore between said forward end portion of said tube and saidrear end portion of said tube, wherein the double-ended needle ismounted centrally and perpendicularly through said member; an arm meanssecured to said support member, wherein said arm means projects throughsaid longitudinal external slot and is movable in a slideable androtatable manner from one transverse slot extension to anothertransverse slot extension to secure said support member in a selectedforward end position or rear end position; a tube rear end cap means toclose said tube rear end; a needle sheath cap means to cover said needlesheath; and a flexible connector means joining said rear end cap andsaid sheath cap.
 2. The device according to claim 1, wherein saidsupport member is a substantially rigid disc rotatably and slideablyencased within said tube bore, wherein said disc has a center axis,axially aligned with the axis of said tube bore, and wherein said dischas two finger tabs connected to said disc by said arm means, the armmeans slideably positioned in and through two longitudinal externalslots.
 3. The device according to claim 1, wherein said transverse slotextension includes a detaining means whereby said arm means is securedwithin said transverse slot extension.
 4. The device according to claim1, wherein the double-ended needle rear end is enclosed by a resealablecover.
 5. The device according to claim 1, wherein said needle sheath isconical with the conical taper away from said tube forward end.
 6. Thedevice according to claim 1, wherein said needle sheath secures saidsheath cap by means of an interlocking holding ring and groove.
 7. Thedevice according to claim 1, further comprising a handling flange atsaid tube rear end.
 8. The device according to claim 1, wherein saidtube rear end cap covers a handling flange at said tube rear end.
 9. Ablood collection device, for use with a double-ended needle,comprising:a tube having forward and rear ends and at least onelongitudinal external slot having a first transverse slot extension insaid tube at a forward end portion and a second transverse slotextension in said tube at a rear end portion, said tube rear endterminating with an open tube bore; a needle sheath, axially alignedwith the axis of the double-ended needle, at said tube forward end; asupport member slideably positioned in said tube bore for movement alongsaid tube bore between said forward end portion of said tube and saidrear end portion of said tube, wherein the double-ended needle ismounted centrally and perpendicularly through said member; an arm meanssecured to said support member, wherein said arm means projects throughsaid longitudinal external slot and is movable in a slideable androtatable manner from one transverse slot extension to anothertransverse slot extension to secure said support member in a selectedforward end position or rear end position; and an exterior tube sleevehaving at least one sleeve longitudinal slot, wherein said sleevelongitudinal slot is opposed to and of equal length to said tubelongitudinal external slot, and wherein said exterior sleeve isrotatably mounted to close said tube longitudinal external slot.
 10. Ablood collection device, for use with a double-ended needle,comprising:a tube having forward and rear ends and two longitudinalexternal slots each having a first transverse slot extension in saidtube at a forward end portion and a second transverse slot extension insaid tube at a rear end portion, said tube rear end terminating with anopen tube bore; a needle sheath, axially aligned with the axis of thedouble-ended needle, at said tube forward end; a substantially rigiddisc rotatably and slideably positioned in said tube bore for movementalong said tube bore between said forward end portion of said tube andsaid rear end portion of said tube, wherein the double-ended needle ismounted centrally and perpendicularly through said disc; an arm meanssecured to said disc, wherein said arm means project through saidlongitudinal external slots and terminate in finger tabs, and whereinsaid arms are movable in a slideable and rotatable manner from onetransverse slot extension to another transverse slot extension to securesaid disc in a selected forward end position or rear end position; atube rear end cap means to close said tube rear end; a needle sheath capmeans to cover said needle sheath; and a flexible connector meansjoining said rear end cap and said sheath cap.
 11. The device accordingto claim 10, wherein said transverse slot extensions include detainingmeans whereby said arm means are secured within said transverse slotextensions.
 12. The device according to claim 10, wherein said needlesheath is conical with the conical taper away from said tube forwardend, and wherein said needle sheath secures a sheath cap by means of aninterlocking holding ring and groove.
 13. The device according to claim10, further comprising a handling flange at said tube rear end.
 14. Thedevice according to claim 10, wherein said tube rear end cap covers ahandling flange at said tube rear end.
 15. A blood collection device,for use with a double-ended needle, comprising:a tube having forward andrear ends and two longitudinal external slots each having a firsttransverse slot extension in said tube at a forward end portion and asecond transverse slot extension in said tube at a rear end portion,said tube rear end terminating with an open tube bore; a needle sheath,axially aligned with the axis of the double-ended needle, at said tubeforward end; a substantially rigid disc rotatably and slideablypositioned in said tube bore for movement along said tube bore betweensaid forward end portion of said tube and said rear end portion of saidtube, wherein the double-ended needle is mounted centrally andperpendicularly through said disc; an arm means secured to said disc,wherein said arm means project through said longitudinal external slotsand terminate in finger tabs, and wherein said arms are movable in aslideable and rotatable manner from one transverse slot extension toanother transverse slot extension to secure said disc in a selectedforward end position or rear end position; and an exterior tube sleevehaving two sleeve longitudinal slots, wherein said sleeve longitudinalslots are adjacent to and of equal length to said tube longitudinalexternal slots, and wherein said exterior sleeve is rotatably mounted toclose said tube longitudinal external slots.
 16. A blood collectiondevice, for use with a double-ended needle, comprising:a tube havingforward and rear ends and at least one longitudinal external slot havinga first transverse slot extension in said tube at a forward end portionand a second transverse slot extension in said tube at a rear endportion; a needle sheath, axially aligned with the axis of thedouble-ended needle, at said tube forward end; a substantially rigiddisc rotatably and slideably positioned in said tube bore for movementalong said tube bore between said forward end portion of said tube andsaid rear end portion of said tube, wherein the double-ended needle ismounted centrally and perpendicularly through said disc; an arm meanssecured to said disc, wherein said arm means project through saidlongitudinal external slots and terminate in finger tabs, and whereinsaid arms are movable in a slideable and rotatable manner from onetransverse slot extension to another transverse slot extension to securesaid disc in a selected forward end position or rear end position; andan exterior tube sleeve having at least one sleeve longitudinal slot,wherein said sleeve longitudinal slot is opposed to and of equal lengthto said tube longitudinal external slot, and wherein said exteriorsleeve is rotatably mounted to close said tube longitudinal externalslot.